A Randomized Trial Comparing Epirubicin/Cyclophosphamide Followed by Weekly Paclitaxel Versus Epirubicin/Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old (PAY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2009 by Fudan University
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01026116
First received: December 3, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.


Condition Intervention Phase
Breast Neoplasms
Drug: A
Drug: B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1664
Study Start Date: December 2009
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: A
    epirubicin/cyclophosphamide followed weekly paclitaxel
    Drug: B
    epirubicin/paclitaxel followed by weekly paclitaxel
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients, age 18~40
  • Unilateral, operable, histologically confirmed adenocarcinoma of the breast
  • Stage I-III
  • Primary surgery with clear margins plus axillary dissection
  • Able to start protocol Rx within 4 weeks of surgery
  • HER-2 positive (IHC 3+ OR FISH+) and sequential use of trastuzumab followed by chemotherapy
  • Occult breast cancer with histologically confirmed primary invasive carcinoma or DICS with microinvasion in the ipsilateral breast after surgery
  • ECOG performance status 0-1
  • Adequate cardiac, renal, hepatic and hematologic function

Exclusion Criteria:

  • Metastatic disease
  • Bilateral breast cancer (synchronous or metachronous)
  • Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
  • Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
  • HER-2 positive (IHC 3+ OR FISH+) and concurrence use of adjuvant chemotherapy and trastuzumab
  • Documented history of cardiac disease contradiction anthracyclines
  • Concurrent serious illness
  • Peripheral neuropathy of CTC grade>1
  • History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026116

Contacts
Contact: Wenjin Yin 86(21)64175590 ext 8700 followroad@yahoo.com.cn

Locations
China
Department of Breast Surgery, Cancer Hospital, Fudan University Not yet recruiting
Shanghai, China, 200032
Contact: Wenjin Yin    86(21)64175590 ext 8700    followroad@yahoo.com.cn   
Principal Investigator: Zhimin Shao         
Department of Breast Surgery, Cancer Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Zhimin Shao    86(21)64175590 ext 8807    zhimingshao1962@yahoo.com.cn   
Contact: Wenjin Yin    86(21)64175590 ext 8700    followroad@yahoo.com.cn   
Principal Investigator: Zhimin Shao         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Zhimin Shao Cancer Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Cancer Hospital, Fudan University, Department of Breast Surgery, Cancer Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01026116     History of Changes
Other Study ID Numbers: SHBCC09007
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Epirubicin
Paclitaxel
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014